Cytodyn Inc (CYDY)

[ClosetInvestor]

“since you have medical proficiency, why could NP not say that they were talking about EUA in PR, rather than just in negotiations with the different agencies?”

This is the first time in biotech/BP history that a company has submitted their data to the FDA (in this case, multiple FDAs) to ask for approval BEFORE announcing success of an endpoint. Look at the previous vaccines and MABs that have been approved for COVID: they announced efficacy first and then that they’d apply for EUA. If the primary endpoint had been met, CYDY would’ve PRed it.

What’s likely happened is that 28 day mortality was not statistically significant, but 42 day (or maybe even 60) mortality is statistically significant along with secondary endpoints. CYDY sent the data to multiple FDAs to see if they can get EUA/approval for these endpoints. Why not PR this? That’s a good question. I feel like EUA is still likely, but not based on 28 day mortality.